FDA Adverse Events Reports (FAERS) Summary for LITHIUM CARBONATE

These tables and charts are based on 17,008 total reports for LITHIUM CARBONATE (LITHIUM CARBONATE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 16,616 pharmaceutical company-submitted and non-U.S. FAERS reports and 392 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 392 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch LITHIUM CARBONATE summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with LITHIUM CARBONATE (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	TOXICITY TO VARIOUS AGENTS	1310
2	DRUG INEFFECTIVE	1134
3	TREMOR	1117
4	DRUG INTERACTION	1046
5	NAUSEA	829
6	WEIGHT INCREASED	811
7	INSOMNIA	724
8	DEPRESSION	714
9	FATIGUE	695
10	VOMITING	689
11	CONFUSIONAL STATE	677
12	DROWSINESS	637
13	ANXIETY	619
14	SUICIDE ATTEMPT	594
15	DIZZINESS	589
16	OFF LABEL USE	585
17	DIARRHEA	575
18	SUICIDAL IDEATION	491
19	FEVER	485
20	HEADACHE	484
21	AGITATION	471
22	OVERDOSE	466
23	THERAPEUTIC AGENT TOXICITY	454
24	FALL	445
25	DIABETES MELLITUS	437
26	LACK OF STRENGTH AND ENERGY (ASTHENIA)	433
27	MANIA	425
28	HIGH BLOOD PRESSURE	408
29	MALAISE	407
30	SHORTNESS OF BREATH	385
31	CONDITION AGGRAVATED	381
32	RASH	374
33	NEUROLEPTIC MALIGNANT SYNDROME	364
34	PAIN	345
35	GAIT DISTURBANCE	344
36	COMPLETED SUICIDE	340
37	LOW BLOOD PRESSURE	340
38	DEHYDRATION	335
39	FEELING ABNORMAL	328
40	SLURRED SPEECH	318
41	CONSTIPATION	314
42	PNEUMONIA	309
43	WEIGHT DECREASED	309
44	ACUTE KIDNEY INJURY	289
45	KIDNEY FAILURE	289
46	AKATHISIA	286
47	PSYCHOTIC DISORDER	281
48	AGGRESSION	279
49	BIPOLAR DISORDER	271
50	PRODUCT USE IN UNAPPROVED INDICATION	269
51	LEUKOPENIA	265
52	MEMORY IMPAIRMENT	265
53	ANTIPSYCHOTIC DRUG LEVEL INCREASED	264
54	IRRITABILITY	262
55	DISORIENTATION	258
56	SEDATION	251
57	RAPID HEART RATE (TACHYCARDIA)	249
58	SEROTONIN SYNDROME	246
59	TYPE 2 DIABETES MELLITUS	246
60	LOSS OF CONSCIOUSNESS	243
61	BLOOD CREATININE INCREASED	242
62	DEATH	239
63	DELIRIUM	237
64	DISTURBANCE IN ATTENTION	237
65	DRUG ABUSE	229
66	DEPRESSED LEVEL OF CONSCIOUSNESS	228
67	KIDNEY IMPAIRMENT	228
68	RENAL FAILURE ACUTE	227
69	DECREASED APPETITE	226
70	EXCESS SWEATING	226
71	ITCHING	224
72	HALLUCINATION	221
73	OBSESSIVE-COMPULSIVE DISORDER	221
74	ANTIPSYCHOTIC DRUG LEVEL BELOW THERAPEUTIC	220
75	INTENTIONAL OVERDOSE	217
76	RESTLESSNESS	217
77	ABNORMAL BEHAVIOUR	216
78	HYPOTHYROIDISM	216
79	MENTAL STATUS CHANGES	216
80	EXTRAPYRAMIDAL DISORDER	212
81	JOINT PAIN	211
82	TARDIVE DYSKINESIA	211
83	INCREASED APPETITE	210
84	LETHARGY	210
85	NEPHROGENIC DIABETES INSIPIDUS	208
86	WHITE BLOOD CELL COUNT INCREASED	208
87	BALANCE DISORDER	204
88	DIFFICULTY SWALLOWING	201
89	AMNESIA	196
90	ATAXIA	196
91	DYSKINESIA	196
92	LOW WHITE BLOOD CELL COUNTS	196
93	OBESITY	196
94	ELECTROCARDIOGRAM QT PROLONGED	194
95	EUPHORIC MOOD	194
96	ABDOMINAL PAIN	192
97	DRUG EFFECT INCOMPLETE	192
98	DRUG LEVEL INCREASED	191
99	VISION BLURRED	191
100	CONVULSION	189

Latest Known Outcomes for Reactions Reported for LITHIUM CARBONATE

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	5683
2	Patient recovered	3180
3	Patient has not recovered/symtoms have not resolved	1793
4	Patient is recovering/symptoms resolving	1736
5	Patient died	490
6	Patient has recovered but has consequent health issues	83

Search all MedWatch and FAERS by keyword:

LITHIUM CARBONATE Total Reports

Male	Female	Unknown	Total
6671	8993	1344	17,008

Top Countries Reporting

	Country	Number of Reports
1	United States	4477
2	Japan	778
3	Canada	692
4	United Kingdom	625
5	Italy	613
6	Germany	343
7	China	223
8	Netherlands	182
9	Australia	171
10	EU	138

Outcomes for Reports

Serious: 13693
Not Serious: 3314
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

Product used for unknown indication
Mania
Bipolar disorder
Bipolar I disorder

Top Companies Reporting

Safety-Related FDA Updates

LITHIUM CARBONATE (LITHIUM CARBONATE) Rx Drug:
Safety-related Labeling Changes

Have experience (good or bad) with LITHIUM CARBONATE? Rate LITHIUM CARBONATE at Ask a Patient.

LITHOBID (LITHIUM CARBONATE) Rx Drug:
Safety-related Labeling Changes

Have experience (good or bad) with LITHOBID? Rate LITHOBID at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

Notes

This report, created by AskaPatient.com, is derived from the cases for LITHIUM CARBONATE reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through April 28, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions or comments about this report.